CARAMEL: Retrospective Study for Personalized Risk Assessment of Cardiovascular Disease in Menopausal and Perimenopausal Women Using Real World Data
NCT ID: NCT06999317
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1500000 participants
OBSERVATIONAL
2025-07-01
2026-06-30
Brief Summary
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The main objective is to improve the prediction of CVD precursors such as hypertension and dyslipidemia, as well as mid- and long-term risk of CVD events, through advanced artificial intelligence (AI) models. These models will be trained on multimodal data to capture complex, individualized risk trajectories that current risk calculators fail to address, particularly in women. Special focus is placed on under-researched, women-specific risk factors and their interactions with traditional predictors.
The study includes several research objectives: (1) predicting the onset of hypertension and dyslipidemia using EHR data; (2) modeling the long-term risk of fatal and non-fatal cardiovascular events and disease trajectories; (3) identifying novel imaging biomarkers from routine screening tests such as mammography, DXA, ultrasound, and cardiac MRI; (4) developing multimodal prediction models combining imaging and clinical data; (5) creating automated AI tools for imaging biomarker extraction; and (6) using signal data from cardiac devices to predict disease progression and events.
The study population consists of middle-aged women with retrospective data available across different health systems. The expected outcome is a validated set of stratified, personalized CVD risk models that can support targeted prevention strategies and enable more equitable, sex-specific care. This will contribute to reducing the burden of CVD in women and addressing critical gaps in early detection, clinical decision-making, and health policy.
This project has received funding from the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No 101156210.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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ASCIRES IMAGE DATABASE
Digital imaging biobank 10y long from several manufact 1,000 cMRI; 500 cardiac CT; 500 coronary artery calcification; 1,000 DXA From women 40- 60y urers / modalities
No interventions assigned to this group
Basque Health Service Database
Longitudinal EHR data up to 15y including diagnosis, procedures, prescriptions, lab tests, visits, imaging, etc.
\~128,00 women 40-60 14,880 DM, 3,124 DXA, 332 carotid US
No interventions assigned to this group
Clalit Primary Prevention Database
Manually curated DB of structured EHR data
\~750,000 middleaged women
No interventions assigned to this group
Irish Implant Devices Registry
Irish Implant Devices Registry (REG) (HRI) 15y of data for implant procedures and follow-ups (pacemakers, ICD's, loop recorders)
\~85,000 implant (pacemaker) proced ures \~700,000 follow-up w. indications \& diagnosis
No interventions assigned to this group
Keralty Colombia Database
EHR data from primary/specialised care centres. Longitudinal EHR data up to 5-10y Including diagnosis, procedures, prescriptions, lab tests, visits, etc.
\~85,593 women 40-60y \~25,000 women with CVD problems
No interventions assigned to this group
Andalusian Health Population Database & Macarena University Hospital EHR
Longitudinal EHR data up to 15y including diagnosis, clinical procedures, prescriptions, lab tests, visits, etc. The hospital Dataset is OMOP CMD mapped
\~700,000 middleaged women
No interventions assigned to this group
Lithuanian High Cardiovascular Risk (LitHiR) primary prevention programme database
EHR data from primary cardiovascular prevention programme in VULSK (1 centre). Data including demographics, risk factors, lab tests (including lipid profile, renal function, etc.), arterial markers (pulse wave velocity analysis data; CardioAngle Vascular Index data; carotid artery intimamedia thickness data).
Some patients have 5-10y longitudinal data with outcomes.
\~6000 women 40-65y with high - very high cardiovascular risk, but without overt CVD;
No interventions assigned to this group
National and Kapodistrian University of Athens Database - Aretaieion Hospital
EHR data from Menopause clinic of Aretaieion university hospital including blood tests, medication, prescriptions, visits
\~4000 middle aged women
No interventions assigned to this group
CoroPrevention - Tampere University (TAU)
Pan-European (25 sites) contemporary prospective CVD prevention cohort from ongoing HEU project it includes clinical data, 3-year CV event data, lifestyle, RFs. Standard + CVD biomarkers (CERT2, hsTNI, NTproBNP, Cystatin C…) N=\~3,000 women (subsample of whole cohort)
No interventions assigned to this group
AKRIBEA - Cooperative Research Centre for Biosciences Association (CIC)
Non-oriented 7y follow-up cohort from Basque Country Region. Urine+serum biomarkers and metabolome; serum lipoproteins by NMR; demographics \& RFs N=\~ 2,500 women (40 to 60 y)
No interventions assigned to this group
MENO - Cooperative Research Centre for Biosciences Association (CIC)
Pre- and post-menopausal women cohort from Basque Country Region. Urine+serum biomarkers and metabolome; serum lipoproteins by NMR; demographics \& RFs N =\~ 1,700 women
No interventions assigned to this group
UK Biobank - UK Biobank
Largest geno-phenotype-rich population-based study in the world (500K), includes multi-modal imaging data (60K) and eye and vision (67K), biomarkers, demographic data, lifestyle (100K with wearables) and health outcomes.
Middle-aged women among:
* 500K baseline
* 60K imaging study
* 67K retina \& OCT
No interventions assigned to this group
Qatar Biobank
Population-based with annotated data, biological samples, tests and imaging for 60K participants. It includes Demographics data, lifestyle, biomarkers, weight \& body fat, hip\&waist, BP, ECG, carotid US, full-body MRI, retinography, DXA Middle-aged women among \~60K total participants
No interventions assigned to this group
International Agency for Research on Cancer (IARC) / EPIC-Europa
Long-term European population-based cohort (520K participants across 10 countries). Includes clinical data, anthropometric measurements, demographic, lifestyle, dietary habits, and socioeconomic data, reproductive history, and biological samples such as serum, plasma and DNA for biochemical data and genotyping data N = \~367k women between 35 to 65 years old (subsample of whole cohort)
\~65k CVD cases across the full cohort
No interventions assigned to this group
ILERVAS -Institute for Research in Biomedicine IRB Lleida
Interventional longitudinal study that includes detailed assessments of subclinical atheromatosis in 12 vascular territories using ultrasound, along with clinical, anthropometric, lifestyle, dietary, and biochemical data.
N = \~4165 women (50 to 70y) (subsample of whole cohort)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
At least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range.
For imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range.
For signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up.
Exclusion Criteria
Insufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile).
Patients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames).
For signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.
40 Years
60 Years
FEMALE
No
Sponsors
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VISUAL INTERACTION & COMMUNICATION TECHNOLOGIES - VICOMTECH
UNKNOWN
Clinic for Cardiovascular Diseases Magdalena
NETWORK
Biokeralty Research Institute
INDUSTRY
Keralty SAS. Colombia
OTHER
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
UNKNOWN
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
University of Dublin, Trinity College
OTHER
TREE Technology S.A.
UNKNOWN
Dublin City University
OTHER
Tampere University
OTHER
Ben-Gurion University of the Negev
OTHER
Biogipuzkoa Health Research Institute
OTHER
Vilnius University Hospital Santaros Klinikos
OTHER
Hospital Universitario Virgen Macarena
OTHER
Responsible Party
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Luis Gabriel Luque Romero
Head of Primary Care Clinical Research Unit
Other Identifiers
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CARAMEL RS
Identifier Type: -
Identifier Source: org_study_id